19 days old

Regulatory Affairs Mgr

Amgen
Thousand Oaks, CA 91360
  • Job Code
    114879206
Amgen

Job ID: R-86380
Location: Thousand Oaks, CA, US 91360

Amgen is seeking a Device Regulatory Affairs Mgr. to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more about this position:

The Device Regulatory Group will build and leverage medical device (combination product, digital health, in vitro diagnostic and innovative technology) capabilities to continuously meet business objectives and compliance needs.

Responsible for:
  • Reporting to the Regulatory Affairs Senior Manager or Director, this role will be responsible for establishing sustainable processes, assuring informed relationships, and delivering strategic outcomes.
  • -Supporting development and implementation of regulatory strategies and processes for new and existing combination products (CPs), digital health (software), in vitro diagnostics and innovative technologies.


Key Activities:

•Perform Registrations and Filings:

• Prepare medical device parts of combination product (CP) in CTDs (M1.2, M2.3 and M3) with RA CMC team.

• Inform on guidance and requirements for device/combination product (CP) clinical and commercial regulatory strategies, filings, and associated Health Agency meetings

• Contribute to medical device regulatory planning documents

• Contribute to medical device determinations

• Identify appropriate external medical device regulatory experts for the technologies (combination products, digital health and in vitro diagnostics)

• Support execution of device-specific filings and associated Health Agency meetings

• Support external reviews (egg, consultants, business partners) of medical device strategies and filing content Regulatory Processes, Initiatives, Teams, and Governance

• Contribute to integration of medical device commercialization and GRAAS processes

• Support development/implementation of regulatory processes and templates for medical device commercialization interfaces

• Under supervision, review and approve device design control deliverables

• Support medical device manufacturing change decisions

• Support medical device regulatory compliance initiatives

• Perform policy reviews for medical device global regulatory guidance/regulations

• Establish sustainable processes

• Assure informed relationships, and deliver strategic outcomes

• Support development and implementation of regulatory strategies and processes for bmedical devices

• Manage and coordinate a device marketing authorization holder renewal application and change notification with the health authorities in cooperation with Safety and Quality

• Mange and coordinate device annual surveillance with the notified body, DEKRA in cooperation with Safety and Quality

• Do a review of MAH-related safety and quality SOPs of medical device from a regulatory perspective of device.

Knowledge and Skills:

•Regulatory principles of medical devices and particularly combination products

•Good knowledge and experience in QMS of medical device , JIS and ISO.
•Working with policies, procedures and SOP's
•Knowledge of national legislation and regulations relating to medical devices
•Awareness of the registration procedures in region for marketing approval/certification, post approval/certification changes.

• Managing and maintaining post-marketing regulatory activities of medical devices
•Knowledge of medical device development

Basic Qualifications:

Doctorate degree

OR

Master's degree and 2 years of Regulatory Affairs experience

OR

Bachelor's degree and 4 years of Regulatory Affairs experience

OR

Associate's degree and 10 years of Regulatory Affairs experience

OR

High school diploma / GED and 12 years of Regulatory Affairs experience

Amgen provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.

Amgen focuses on areas of high unmet medical needs and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

PI114879206

<b>Amgen</b><br/><br/><b>Job ID: </b>R-86380<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is seeking a Device Regulatory Affairs Mgr. to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more about this position: <br><br>The Device Regulatory Group will build and leverage medical device (combination product, digital health, in vitro diagnostic and innovative technology) capabilities to continuously meet business objectives and compliance needs.<br><br>Responsible for:<br><ul><li>Reporting to the Regulatory Affairs Senior Manager or Director, this role will be responsible for establishing sustainable processes, assuring informed relationships, and delivering strategic outcomes.</li><li>-Supporting development and implementation of regulatory strategies and processes for new and existing combination products (CPs), digital health (software), in vitro diagnostics and innovative technologies.</li></ul><br><br><b>Key Activities:</b><br><br>Perform Registrations and Filings:<br><br> Prepare medical device parts of combination product (CP) in CTDs (M1.2, M2.3 and M3) with RA CMC team.<br><br> Inform on guidance and requirements for device/combination product (CP) clinical and commercial regulatory strategies, filings, and associated Health Agency meetings<br><br> Contribute to medical device regulatory planning documents<br><br> Contribute to medical device determinations<br><br> Identify appropriate external medical device regulatory experts for the technologies (combination products, digital health and in vitro diagnostics)<br><br> Support execution of device-specific filings and associated Health Agency meetings<br><br> Support external reviews (egg, consultants, business partners) of medical device strategies and filing content Regulatory Processes, Initiatives, Teams, and Governance<br><br> Contribute to integration of medical device commercialization and GRAAS processes<br><br> Support development/implementation of regulatory processes and templates for medical device commercialization interfaces<br><br> Under supervision, review and approve device design control deliverables<br><br> Support medical device manufacturing change decisions<br><br> Support medical device regulatory compliance initiatives<br><br> Perform policy reviews for medical device global regulatory guidance/regulations<br><br> Establish sustainable processes<br><br> Assure informed relationships, and deliver strategic outcomes<br><br> Support development and implementation of regulatory strategies and processes for bmedical devices<br><br> Manage and coordinate a device marketing authorization holder renewal application and change notification with the health authorities in cooperation with Safety and Quality<br><br> Mange and coordinate device annual surveillance with the notified body, DEKRA in cooperation with Safety and Quality<br><br> Do a review of MAH-related safety and quality SOPs of medical device from a regulatory perspective of device.<br><br><b>Knowledge and Skills:</b><br><br>Regulatory principles of medical devices and particularly combination products<br><br>Good knowledge and experience in QMS of medical device , JIS and ISO.<br>Working with policies, procedures and SOP's<br>Knowledge of national legislation and regulations relating to medical devices<br>Awareness of the registration procedures in region for marketing approval/certification, post approval/certification changes. <br><br> Managing and maintaining post-marketing regulatory activities of medical devices <br>Knowledge of medical device development<br><br><b>Basic Qualifications:</b><br><br>Doctorate degree<br><br>OR<br><br>Master's degree and 2 years of Regulatory Affairs experience<br><br>OR<br><br>Bachelor's degree and 4 years of Regulatory Affairs experience<br><br>OR<br><br>Associate's degree and 10 years of Regulatory Affairs experience<br><br>OR<br><br>High school diploma / GED and 12 years of Regulatory Affairs experience<br><br><b> Amgen </b> provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow. <br><br><b> Amgen </b> focuses on areas of high unmet medical needs and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. <br><br>Join Us <br> <br> If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. <br> <br> Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. <br> <br> As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. <br> <br> Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.<br/><br/> <img src="https://analytics.click2apply.net/v/NaAmXJSj21wdcRBOuqRMb"> <p>PI114879206</p>

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Posted: 2019-10-25 Expires: 2019-11-25

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Regulatory Affairs Mgr

Amgen
Thousand Oaks, CA 91360

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